Assess ®

GUDID 00613994798398

PROG 7436 KINETRA EZ PATIENT US MKT

MEDTRONIC, INC.

Active-implantable-device communicator

• Primary Device ID: 00613994798398
• NIH Device Record Key: dd72ec75-5bbb-4878-a596-dc202e80267f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assess ®
• Version Model Number: 7436
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994798398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H050003

FDA Product Code

• MHY: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

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• 00763000879297 - NA: 2025-02-18 TELEMETRY TM90Q0 ISTIM X US EMAN
• 00763000988777 - NA: 2025-02-17 CUSTOM PACK BB6Z71R15 VA
• 20763000998145 - NA: 2025-02-17 CUSTOM PACK SSBB12N37R 10PK LOWER LMB
• 00763000998424 - NA: 2025-02-17 CUSTOM PACK BB10Z65R1 V A D
• 00763000517830 - Hancock™: 2025-02-14 CONDUIT HC15022 HK1 MO 26L
• 00763000995775 - NA: 2025-02-14 CUSTOM PACK BB11W65R2 SPECTRUM CPB